Model Number 11500A |
Device Problems
Fluid/Blood Leak (1250); Perivalvular Leak (1457)
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Patient Problem
Heart Failure/Congestive Heart Failure (4446)
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Event Date 11/06/2023 |
Event Type
Injury
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Event Description
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It was reported a 21mm 11500a aortic valve implanted four (4) years, two (2) months, was explanted due to severe insufficiency and perivalvular leak (pvl).Per medical records, the patient presented with heart failure.Approximately six (6) months after implant of the 21mm 11500a aortic valve the patient was found on echo to have significant aortic insufficiency (pvl).Patient was somewhat short of breath but was able to be treated medically.Recent tee showed now new severe mitral regurgitation secondary to new pvl.Aortic valve was felt to still be severe aortic insufficiency and pvl.Patient underwent full sternotomy.There is a large pvl in the left sinus.The explanted 21mm 11500a aortic valve was replaced with another 21mm 11500a aortic valve.The patient also underwent re-do mitral valve replacement.Postprocedural tee revealed no pvl in mitral or aortic prosthesis with very good function.
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Manufacturer Narrative
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The device was not returned to edwards for evaluation as it is not available.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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Manufacturer Narrative
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The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.
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Search Alerts/Recalls
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